sustained treatment of paroxysmal atrial fibrillation post-approval study (stop af pas)

Conditions: Paroxysmal Atrial Fibrillation (PAF)

Summary: the post-approval study (pas) is a prospective multi-center, non-randomized, single arm, controlled,unblinded clinical study designed to provide long-term safety and effectiveness of the arctic front® cardiac cryoablation system.

safety and effectiveness will be evaluated against pre-specified performance criteria as determined by the sponsor and fda. the criteria set in this study have been previously used to demonstrate safety and effectiveness in cryoablation and radio-frequency ablation for the treatment of paroxysmal atrial fibrillation. the analyses of the primary effectiveness objective will take place once all the subjects with a study cryoablation procedure attempt have reached 36 months of follow-up post-cryoablation procedure. the analysis of the primary safety objective will take place once all the subjects with a study cryoablation procedure attempt have reached 12 months of follow-up post-cryoablation procedure. the analyses for the secondary objectives will take place once all subjects with a study cryoablation attempt have reached 36 months of follow-up post-cryoablation procedure.

Eligibility criteria:
inclusion criteria: 1. documented paf: * diagnosis of paroxysmal atrial fibrillation (paf), and * 2 or more episodes of af during the 3 months preceding the consent date, and * at least 1 episode of af documented with a tracing within 12 months preceding the consent date. 2. age 18 years or older 3. failure for the treatment of af (effectiveness or intolerance) of at least one membrane active aad for rhythm control. exclusion criteria: 1. any previous left atrial (la) ablation (except permissible retreatment subjects) 2. any previous la surgery 3. current intracardiac thrombus (can be treated after thrombus is resolved) 4. presence of any pulmonary vein stents 5. presence of any pre-existing pulmonary vein stenosis 6. pre-existing hemidiaphragmatic paralysis 7. anteroposterior la diameter \> 5.5 cm by tte 8. presence of any cardiac valve prosthesis 9. clinically significant mitral valve regurgitation or stenosis 10. myocardial infarction, pci / ptca or coronary artery stenting which occurred during the 3 month interval preceding the consent date 11. unstable angina 12. any cardiac surgery which occurred during the 3 month interval preceding the consent date 13. any significant congenital heart defect corrected or not (including atrial septal defects or pulmonary vein abnormalities but not including minor pfo) 14. nyha class iii or iv congestive heart failure 15. left ventricular ejection fraction (lvef) \< 40% 16. 2º (type ii) or 3º atrioventricular block 17. presence of a permanent pacemaker, biventricular pacemaker, atrial defibrillator or any type of implantable cardiac defibrillator (with or without biventricular pacing function) 18. brugada syndrome 19. long qt syndrome 20. arrhythmogenic right ventricular dysplasia 21. sarcoidosis 22. hypertrophic cardiomyopathy 23. known cryoglobulinemia 24. uncontrolled hyperthyroidism 25. any cerebral ischemic event (strokes or tias) which occurred during the 6 month interval preceding the consent date. 26. any woman known to be pregnant 27. life expectancy less than one (1) year 28. current or anticipated participation in any other clinical trial of a drug, device or biologic during the duration of this study not pre-approved by medtronic 29. unwilling or unable to comply fully with study procedures and followup

Keywords: atrial fibrillation (af) paroxysmal atrial fibrillation (paf) arrythmias cardiac arrythmias cardiac ablation cryoablation